• Harvoni is a combination tablet containing ledipasvir and sofosbuvir. It may be used to treat certain genotypes of the hepatitis C virus in adults and children over the age of three.
• Ledipasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself
• Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself. The ingredients in Harvoni initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus.
• Harvoni belongs to the class of medicines known as hepatitis C antivirals. It may also be called a combination antiviral agent.

• Harvoni is a combination tablet containing ledipasvir and sofosbuvir that may be used to treat certain genotypes of hepatitis C (HCV) in adults and children 3 years of age and older.
• Harvoni is approved for HCV genotypes 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; genotype 1 infection with decompensated cirrhosis in combination with ribavirin; and genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis in combination with ribavirin.
• Harvoni is a single combination pill that is given by mouth once a day for 12 or 24 weeks, depending on the presence of compensated cirrhosis (Child-Pugh A).
• Harvoni is available as oral tablets or pellets which are more easily swallowed.
• Harvoni may be taken with or without food.
• Usually, the side effects that occur with Harvoni are mild. Clinical studies report only 1% (1 out of 100) or less of patients stopped treatment due to side effects.
• Harvoni eliminates the hepatitis C virus in 95% of people who take it for the recommended number of weeks, technically curing them.
• The dosage of Harvoni does not need to be modified in those with kidney disease, including those with end-stage renal disease (ESRD) on dialysis.
• Gilead, the manufacturer of Harvoni, has a special patient assistance program called Support Path™ that may assist with co-pay insurance coupons or make Harvoni available at no charge for eligible and qualified uninsured patients.
• Harvoni is also available as a cost-saving generic called ledipasvir/sofosbuvir.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Most side effects that occur with Harvoni are mild but the most common ones reported were fatigue, headache, nausea, diarrhea, and insomnia. Other side effects include asthenia (lack of energy), cough, myalgia (muscle pains), dyspnea (shortness of breath), irritability, dizziness, and skin rashes.
• Weight gain has not been reported in clinical trials as a side effect of Harvoni.
• Reactivation of hepatitis B has been reported. All patients should be tested for current or prior hepatitis B virus (HBV) infection before initiating treatment with Harvoni.
• Harvoni is expensive. Twenty-eight Harvoni 45mg/200mg oral tablets cost around $32,896. An eight-week treatment course is approximately $65,000, a 12-week course is $98,500, and a 24-week course is around $197,000 without insurance or funding. However, most insurance companies and Medicare cover Harvoni if you meet certain criteria but there may be a co-pay.
• Harvoni is usually taken for 12 weeks but may be taken for 24 weeks in people with compensated cirrhosis. The dosage of Harvoni may need to be adjusted in people with both HIV and HCV.
• Harvoni may cause elevations in laboratory levels of bilirubin, lipase, and creatinine kinase.
• There is limited data as to the effects of Harvoni on a developing fetus. Tell women of childbearing potential to use adequate contraception to ensure they do not become pregnant while taking Harvoni. The effects of Harvoni on a breastfeeding infant are also not known.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before you start taking Harvoni your doctor will test you for hepatitis B virus (HBV) infection. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Harvoni is started.
• Harvoni pellets may be used to treat HCV in children or in those who have difficulty swallowing. Harvoni pellets should not be chewed. Harvoni pellets may be sprinkled on top of non-acidic soft foods such as pudding, chocolate syrup, mashed potato, or ice cream that is at or below room temperature. The mixture of foods and pellets should be swallowed whole within 30 minutes of mixing to avoid a bitter aftertaste. Do not store any leftover mixture.
• Harvoni is best taken at the same time every day. Follow your physician's advice with regard to the dosage of Harvoni and do not miss or skip doses. Take Harvoni for the duration that is recommended by your physician.
• Tell your doctor if you take any other medications or supplements, including those purchased from a supermarket or health store. Some medications, such as amiodarone, should not be taken with Harvoni.
• Seek urgent medical attention if you develop a very slow heartbeat, feel faint or unwell, or experience symptoms such as dizziness or lightheadedness, weakness, excessive tiredness, shortness of breath, chest pains, confusion, or memory problems.
• There is limited data as to the effects of Harvoni on a developing fetus. If you are taking Harvoni with ribavirin, you should use adequate contraception to ensure you do not become pregnant. If you do become pregnant while taking Harvoni, see your doctor immediately. The effects of Harvoni on a breastfeeding infant are also not known.
• While you are taking Harvoni to treat hepatitis C, you should take steps to ensure you do not pass HCV to others. This includes not sharing needles and practicing safe sex.

• Harvoni eliminates the hepatitis C virus in 95% of people who take it for the recommended number of weeks, technically curing them. A cure is defined as a lack of detection of the hepatitis C virus in the blood for 12 weeks. However, a person can become reinfected with the hepatitis C virus if they are exposed to it again.
• Because ledipasvir works directly on the virus not on human cells by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself, it has very few side effects. Sofosbuvir also works directly on viral RNA and does not inhibit human DNA or RNA.

Medicines that interact with Harvoni may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Harvoni. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Harvoni include:

• acid-reducing agents, such as antacids (eg, aluminum and magnesium hydroxide), H2 receptor antagonists (eg, famotidine), and proton pump inhibitors (such as omeprazole)
• amiodarone (not recommended because symptomatic bradycardia, fatal cardiac arrest, and pacemaker intervention have occurred)
• anticonvulsants, such as carbamazepine, phenytoin or phenobarbital
• antimicrobials, such as rifabutin or rifampin
• digoxin
• HIV medications, such as elvitegravir, emtricitabine, tenofovir, tipranavir, ritonovir, or cobicistat
• HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, or rosuvastatin
• inducers of P-glycoprotein such as carbamazepine, dexamethasone, doxorubicin, nefazodone, phenobarbital, phenytoin, prazosin, rifampicin, St. John's wort, tenofovir, tipranavir, trazodone, and vinblastine.
• other HCV products such as simeprevir.

Harvoni is often given in combination with ribavirin. All the medications that interact with ribavirin will also interact with this combination. In addition, women taking ribavirin should not become pregnant while taking ribavirin.

Note that this list is not all-inclusive and includes only common medications that may interact with Harvoni. You should refer to the prescribing information for Harvoni for a complete list of interactions.